Kornimate/medical-research-clean huggingface dataset:
trial to evaluate the safety and immunogenicity of a multivalent pneumococcal conjugate vaccine in adults 60 through 64 years of age

Conditions: Pneumococcal Infections

Summary: this is a phase 2, randomized, double-blinded study with a 2-arm parallel design. healthy adults aged 60 through 64 years of age with no history of pneumococcal vaccination will be randomized equally to receive either a single intramuscular dose of multivalent pneumococcal conjugate vaccine followed 1 month later with a dose of saline or prevnar 13 followed 1 month later with a dose of ppsv23 (control group).


Eligibility criteria:
inclusion criteria: 1. male or female adults \>/= 60 to \</=64 years of age (from the 60th birthday up to, but not including, the 65th birthday) at enrollment. 2. healthy adults, including adults with preexisting stable disease, defined as disease not requiring significant change in therapy or requiring hospitalization within 3 months before receipt of investigational product, as determined by medical history, physical examination, laboratory screening, and clinical judgment of the investigator. 3. female subjects who are not of childbearing potential. exclusion criteria: 1. previous vaccination with any licensed or investigational pneumococcal vaccine, or planned receipt through study participation. 2. history of microbiologically proven invasive disease caused by s pneumoniae. 3. serious chronic disorder including metastatic malignancy, severe chronic obstructive pulmonary disease (copd) requiring supplemental oxygen, end-stage renal disease with or without dialysis, clinically unstable cardiac disease, or any other disorder that, in the investigator's opinion, excludes the subject from participating in the study.
the relationship between ambulation capacity and piriformis muscle in patients with chronic spinal cord injury

Conditions: Spinal Cord Injuries

Summary: spinal cord injury (sci) is a neurological condition causing paralysis, sensory abolishments and deficits including circulatory, respiratory, otonomic nervous systems, bowel and bladder functions. for patients with sci, reducing disability, limitations of the impairment and regaining the walking ability are the main rehabilitation goals. there many prognostic factors effecting the recovery and ambulation capacity of patients. the piriformis muscle (pm) is placed posterior to the hip joint, originates on the anterior surface of the sacrum and the sacrotuberous ligament and passes out of the pelvis through the greater sciatic foramen and separates the foramen into two spaces. the pm is the solely muscle coursing transversely throughout the greater sciatic notch, and it is the main landmark to all the important neurovasculer structures that pass from the pelvis to the gluteal region. pm serves as a hip abductor when the hip is flexed and as a hip external rotator when the hip is extended. it is innervated by branches of the posterior division of the ventral rami of s1, s2 and is the largest muscle among the deep, short external rotators of the hip and provides postural stability while standing and walking. pm has also a functional importance as it connects the sacroiliac joint and hip joint. for these reasons morphology of pm may have a clinical importance for sci patients whom can walk. ultrasonography is radiation-free, noninvasive, available technique that can be used to measure muscle thickness in the monitoring and management of muscle changes during rehabilitation. the aim of our study is to evaluate the relationship between the pm and the ambulation pattern of motor incomplete patients with chronic sci. to the best of our knowledge, this is the first study evaluating pm in patients with sci.


Eligibility criteria:
inclusion criteria: * being between the ages of 18-65 * diagnosis of motor incomplete paraplegia at c or d level according to the spinal cord injury classification of the american spinal injury association (asia) impairment scale with a neurological injury level between t2-s1 exclusion criteria: * being under the age of 18 and over the age of 65 * having joint contracture in the legs * unstable medical conditions * severe osteoporosis and high fracture risk * sacral or coccygeal grade 2 and higher pressure ulcers * peripheral neuropathy, * psychiatric disorder or cognitive problems

Keywords: spinal cord injury piriformis muscle ultrasonographic evaluation
corever in the treatment of hypertension

Conditions: Hypertension

Summary: the study primarily aims to compare the effects of two doses of corever with placebo in patients with hypertension.

the study aims to compare the effects of two doses of corever with placebo in patients with essential hypertension. eligible subjects who belong to one of the following subtypes are planned to be enrolled: (1) patients with essential hypertension without drug control, or (2) uncontrolled hypertension despite treatment with up to 2 antihypertensive agents. of note, the second category will receive randomized study treatments in addition to continuing their previous medication throughout the trial. the study also wants to investigate the safety profile of corever during treatment period.

Eligibility criteria:
inclusion criteria: 1. patients who are 20-90 years of age 2. patients who belong to either one of the following categories: with essential hypertension, as measured by office bp and are not on antihypertensive treatment at screening . with uncontrolled hypertension despite treatment with up to 2 antihypertensive agents, and the type and dose of the agents shall be maintained for at least 28 days prior to entering this trial. 3. agree to and are able to follow the study procedures. 4. understand the nature of the study, and have signed informed consent forms. exclusion criteria: 1. patients with any of the following conditions: * malignant hypertension * secondary hypertension * average sitting sbp ≥ 180 mmhg * advanced hypertensive retinopathy * type 1 diabetes * acute coronary syndrome * clinical significant valvular disease * hypertrophic cardiomyopathies * new york heart association class iii -iv congestive hf * second or third degree atrioventricular block or history of sick sinus syndrome unless a pacemaker is in place * atrial fibrillation * sinus bradycardia (\<60 bpm) * asthma * stroke within 3 months * cancer with expected survival less than 3 years * a difference of \> 20 mmhg for sbp or \> 10 mmhg for dbp between arms at screening * severe hepatic impairment * a history of a serious hypersensitivity reaction. 2. patients with clinically significant abnormalities. 3. patients with known contraindication to corever. 4. female patients who are pregnant or lactating. 5. 5. male or female patients of child-bearing potential who do not agree to use an effective method of contraception during the study. 6. patients is currently participating in any other clinical trial within 30 days 7. patients need to be treated with the permitted medication.

Keywords: corever hypertension
tobacco approach avoidance training for adolescent smokers-2

Conditions: Tobacco Use Disorder

Summary: this is a two part study. in study 2, smokers who want to quit smoking will participate in a 4 week smoking cessation program combining weekly cognitive behavioral therapy (cbt) with weekly regular-aat or placebo-aat training. we hypothesize that adolescent smokers will exhibit stronger approach tendencies towards smoking-related stimuli in the tobacco approach avoidance training (aat) task when compared with nonsmokers and that adolescent smokers who are trained to avoid smoking related stimuli using the aat will avoid tobacco approach tendencies in the aat test trials and the implicit association task, when compared to adolescent smokers who are not exposed to aat training. we also hypothesize that adolescent smokers who are trained to avoid tobacco in a training aat in combination with cbt will have better abstinence rates compared to those who receive placebo aat training with cbt.


Eligibility criteria:
inclusion criteria: * inclusion criteria: * between ages 13-18 years * able to read and write in english. * smokers: smoking 5 or more cigarettes daily for at least 6 months; baseline urine cotinine levels \> 500 ng/ml * nonsmokers: never smokers; baseline urine cotinine levels \< 50 ng/ml exclusion criteria: * current criteria for dependence on another psychoactive substance * current diagnosis of psychosis, major depression or panic disorder * regular use of any psychoactive drugs including anxiolytics and antidepressants unless the medication has been taken consistently for 2 months, is currently being monitored by a physician, and the condition for which the medication is taken is considered to be stable * pregnant or lactating girls, based on self report.

Keywords: nicotine smoking adolescent tobacco
pancreatic cancer recurrence in the netherlands

Conditions: Pancreatic Ductal Adenocarcinoma; Pancreatic Cancer; Pancreas Cancer; PDAC

Summary: the aim of this nationwide, observational cohort study is to evaluate current surveillance strategies after primary resection of pancreatic ductal adenocarcinoma (pdac) in the netherlands, with regard to the detection, treatment and survival of pdac recurrence.


Eligibility criteria:
inclusion criteria: * patients undergoing a pancreatic resection (pppd, whipple, distal pancreatectomy or total pancreatectomy) for histologically proven pdac in one of the 16 dutch centers for pancreatic surgery exclusion criteria: * patients with 30-day postoperative mortality
feasibility of a technology-based treatment support system

Conditions: Depression; Depressive Disorder, Major

Summary: this study aims to evaluate a technology-based treatment support system for patients undergoing the treatment of depression. the investigators will explore the usefulness of the technology-based treatment support system as an adjunct to psychotherapy for depression.

this study aims to evaluate a technology-based treatment support system "mconnect" for patients undergoing the treatment of depression. this system will be evaluated by conducting a randomized controlled trial where patients will either receive the mconnect mobile app or treatment as usual.

Eligibility criteria:
inclusion criteria: * 18 years of age or older * english-speaking * currently enrolled in outpatient treatment * current diagnosis of major depressive disorder * ownership of a smartphone device compatible with the mobile app exclusion criteria * visual, hearing, voice, or motor impairment that would prevent completion of the study procedures or use of mobile phone * diagnosis of a psychotic disorder, bipolar disorder, dissociative disorder, substance use disorder, or other diagnosis for which participation in this trial is inappropriate, severe suicidality (has ideation, plan, and intent). * having completed more than 3 sessions of psychotherapy with current therapist
implantation of continent catheterizable channel : native bladder or enterocystoplasty ?

Conditions: Neurogenic Bladder; Continent Cutaneous Urinary Diversion; Mitrofanoff

Summary: purpose. to compare the results between two sites of implantation of the continent catheterizable channel (ccc): native bladder or enterocystoplasty. methods. retrospective monocentric study of pediatrics and adult patients who underwent a continent cystostomy between 1991 and 2020 with a continent catheterizable channel implanted in the native bladder's detrusor (d group) or the enterocystoplasty (ec group).

this is a monocentric and retrospective study involving adult and pediatric population who underwent the creation of a ccc between june 1991 and january 2020. two different surgical techniques were performed: on the first hand, the implantation of the channel in the native bladder's detrusor (d group), on the other hand the implantation of the channel by seromuscular plicature on the anterior wall of the enterocystoplasty (ec group). the ccc were made from the appendix, an ileal or sigmoid segment, an ureter or a skin flap. bladder augmentation and cervicoplasty (kropp, kurzrock, young-dees, artificial urinary sphincter, sling suspension of the bladder neck, closure of the bladder neck) were frequently associated. the following informations were obtained in all included patients by charts reviews: age at surgery, gender, main underlying pathology, details of operative reports with the type of channel, bladder augmentation and/or associated cervicoplasty, early postoperative complications, complications appearing during the follow up period and the requirement of surgical or non-surgical revision, finally the channel continence at the last follow up.

Eligibility criteria:
inclusion criteria: * adult and pediatric patients who underwent a surgery for creation of a continent catheterizable channel * between 1991 and 2020 * in the pediatric surgery or urology department at nancy university hospital exclusion criteria: * ghoneim technique used for implantation

Keywords: native bladder enterocystoplasty continent catheterizable channel neurogenic bladder
immunopet imaging of pancreatic cancer

Conditions: Neoplasms Pancreatic

Summary: pancreatic cancer remains one of the most aggressive cancer types. target-specific targeted therapy is an attractive therapeutic alternative for the treatment of patients with a wide range of cancers, including pancreatic cancer. companion diagnostic technique is critical for the success of targeted therapies. shr-a1921 is a trop2-directed antibody-drug-conjugate (adc) approved for several clinical trials for advanced solid tumors. shr1920 is the humanized anti-trop2 monoclonal antibody (higg1) of shr-a1921. radio-labeling shr1920 with radionuclide zirconium-89 (89zr) enables non-invasive imaging and quantification of shr-a1921 distribution in cancer patients. performing a \[89zr\]zr-dfo-shr1920 pet scan before treatment with shr-a1921 can evaluate tracer uptake in the primary and metastatic tumor lesions and normal organ distribution. clnd18.2 is another potential therapeutic target for pancreatic cancer. target-specific immunopet imaging may help identify patients more likely to benefit from targeted therapy.

enrolled patients with pancreatic cancer will undergo whole-body \[89zr\]zr-dfo-shr1920 immunopet/ct scans at 0,1, 3, 5, or 7 days after tracer injection (1-3 mci). uptake of \[89zr\]zr-dfo-shr1920 in tumor and normal organs/tissues will be scored visually and quantitatively. for immunopet imaging with 18f or 68ga-labeled 3a12 (a nanobody targeting cldn18.2), immunopet/ct scan will be performed 1h after tracer injection (0.05-0.1 mci/kg). tumor uptake will be quantified by the maximum standard uptake value (suvmax). the sensitivity, specificity, positive predictive value (ppv), negative predictive value (npv), and accuracy will be calculated to evaluate the diagnostic efficacy. the correlation between lesion uptake and protein expression level determined by immunohistochemistry staining will be further analyzed. the exploration endpoint will be the imaging feasibility and preliminary diagnostic value of the above tracers.

Eligibility criteria:
inclusion criteria: * histologically confirmed diagnosis of pancreatic cancer or suspected pancreatic cancer by diagnostic imaging. * capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (icf) and in this protocol. exclusion criteria: * known or suspected hypersensitivity to shr1920, dfo/resca/nota, 89zr/18f or 68ga or any of the excipients. * pregnancy

Keywords: pancreatic cancer immunopet companion diagnostics trop2 cldn18.2（claudin 18.2） gastric cancer solid tumors
effects of a structured education program on blood pressure in essential hypertensive patients

Conditions: Hypertension

Summary: the purpose of this study is to evaluate the effects of a structured educational program for hypertensive patients. the program was developed at the university of dusseldorf, germany. the contents of the program are as follows: teaching of the background of hypertension, techniques of self estimation of blood pressure, life style and dietary habits, some information concerning the different pharmacological properties to treat hypertension

see brief description section

Eligibility criteria:
inclusion criteria: * intellectual and physical ability to attend teaching program, * capability to do and document blood pressure self-measurement, * systolic blood pressure \>160 and/or diastolic blood pressure \>95 mmhg, * at least 3 months of preexisting medicamentous anti-hypertensive treatment, * 15% or higher risc in new zealand risc scale exclusion criteria: * failing inclusion criteria

Keywords: hypertension self measurement of blood pressure education program life style
the age of orthoinfo: a randomized controlled trial evaluating patient comprehension of informed consent in a private practice

Conditions: Knee Osteoarthritis

Summary: the aim of the study is determine which method of informed consent improves comprehension in college educated patients in a private practice setting.


Eligibility criteria:
inclusion criteria: * knee osteoarthritis patients over the age of 18 with a college education deemed appropriate for medical management with a knee injection. exclusion criteria: * patients without the capacity to provide consent * patients with a visual, auditory, psychological or tactile impairment requiring the assistance of another person.
management and outcome of fever in children in europe

Conditions: Antibiotic Prescription

Summary: this is an observational study assessing the management and outcome of children presenting to emergency departments (ed) with fever across europe.

this is an observational study assessing the management and outcome of children presenting to emergency departments (ed) with fever across europe. this study will use large departmental datasets to collect information on at least 50,000 febrile episodes . this study will use large-scale, pseudo-anonymized departmental data, and will not involve consented patient recruitment; nor will it use patient samples. data included in mofiche will be based on that collected as part of routine clinical care. antibiotic prescription, hospitalisation and number/type of investigations, re-attendance at ed within 5 days of the first hospital presentation will be recorded.

Eligibility criteria:
inclusion criteria: * aged 0- 18 years visiting the emergency care. * fever measured at ed or history of (measured) fever less than 3 consecutive days prior to presentation at emergency department exclusion criteria: -
treatment for patients with non-myeloid malignancies receiving chemotherapy

Conditions: Cancer; Non-Myeloid Malignancies

Summary: the purpose of this study is to compare the time to hematopoietic response (hemoglobin correction to 12 g/dl or a greater than or equal to 2 g/dl increase from baseline) for subjects randomized to receive darbepoetin alfa with a front load dosing regimen to those receiving recombinant human erythropoietin (rhuepo) with a weekly dose regimen during the 12-week comparative treatment period.


Eligibility criteria:
inclusion criteria: * subjects with non-myeloid malignancies planning to receive cyclic chemotherapy for 8 additional weeks or more * anemia (hemoglobin \[hgb\] greater than or equal to 9.0g/dl and less than or equal to 11.0 g/dl) related to cancer and chemotherapy * karnofsky performance status of greater than or equal to 50% * serum bilirubin less than or equal to 2.5 times the upper limit of normal range and serum creatinine concentration of less than or equal to 2.0 mg/dl exclusion criteria: * acute myelogenous leukemia (aml), chronic myelogenous leukemia (cml), or myelodysplastic syndromes * hematologic disorder previously associated with anemia * active bleeding * iron deficiency * received erythropoietic therapy within 14 days prior to randomization * unstable cardiac disease * known positive human immunodeficiency virus antibody or hepatitis b surface antigen * known positive antibody response to any erythropoietic agent * currently enrolled in, or has not yet completed at least 30 days since ending other investigational device or drug trial or is receiving investigational agent(s) not approved for any indication * pregnant or breast feeding * red blood cell (rbc) transfusion within 4 weeks of screening * known hypersensitivity to any recombinant mammalian-derived product

Keywords: darbepoetin alfa anemia amgen chemotherapy
ultrasound-guided regional anesthesia vs local infiltration anesthesia with dexmedetomidine and ropivacaine

Conditions: Pain, Postoperative; Anesthesia, Local; Gonarthrosis

Summary: evaluation of the impact of dexmedetomidine as an adjunct for local infiltrations analgesia and ultrasound-based regional anaesthesia as pain medication in regard to patients' opioid need the first 48 hours after the total knee replacement operation.

evaluation of the impact of dexmedetomidine as an adjunct for local infiltrations analgesia and ultrasound-based regional anaesthesia as pain medication in regard to patients' opioid need the first 48 hours after the total knee replacement operation. secondary objectives are: pain assesment, pain medication necessary, functionality of the prothesis, satisfaction, wellbeing, postoperative discomforts, complications (delirium, allergic reactions, cardiopulmonary decompensation), procedure specific time.

Eligibility criteria:
inclusion criteria: * adult * non pregnant * patients with gonarthrosis who have given written consent for participation exclusion criteria: * age below 18 years * pregnancy * breast-feeding patients * allergies against study medication * missing or denied written consent